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The client contacted The Pinnacle Health Group thirteen months following FDA approval. The company had been without reimbursement for costly technology for over a year and the ability to market the technology was difficult. The company requested assistance achieving appropriate reimbursement and procedure/device codes for future payment. The company also faced other payer related issues including; a negative Blue Cross Technology Assessment, limited positive payer policies and difficult physician reimbursement.


The Pinnacle Team evaluated the current policies, reimbursement and coverage issues by investigating current coverage policies at over forty insurance plans including Medicare. The general consensus was that the technology was not proven safe and effective as a standalone treatment. This was further supported by the BCBS Association unfavorable technology assessment. Pinnacle contacted the BCBS Association to better understand the data reviewed as part of the technology assessment. It was determined that current published data was not utilized by the TEC review committee which caused the committee to define the technology as "experimental and investigational". Pinnacle provided copies of the most up to date clinical literature and requested an immediate review and update of the technology.

The Pinnacle Health Group immediately assessed current coding that would permit physicians to receive reimbursement for the technology and implant of the device. This permitted physicians to continue to purchase the technology and offer patients treatment alternatives, as appropriate. Appeal and precertification tools were developed for physicians and hospitals giving them a support mechanism to request appropriate coverage and payment.

Pinnacle initiated a review of current coding applications that were submitted and pending or denied by governmental agencies. It was immediately determined that the inappropriate coding was requested and that governmental agencies could not approve coding for the new technology because the application criteria was not met. Pinnacle completed and submitted appropriate temporary coding applications within one month and new permanent codes were requested within three months of project initiation.


Two new APC procedure codes were approved by CMS within five months of application. The new technology APC codes permitted appropriate reimbursement for hospitals until new permanent codes were approved by the AMA. Updated coding tools and documents were provided to all customers and webcasts provided physicians and hospitals with appropriate coding information. CPT codes were approved by the AMA within eighteen months. The new CPT codes are the first brachytherapy codes to include the cost of the device as well as other technical component costs. By working directly with providers and payers, patients have received favorable coverage and policies have been developed at over thirty seven payers across the country. Company sales doubled following approval of appropriate reimbursement and Pinnacle now provides ongoing hotline service for customers requiring coding, billing and coverage advice.


The clinical studies not only supported the improvement of quality of life in patients but it indicated significant long term cost savings for the health care system. A few months before expected FDA approval, there was no reimbursement strategy for the product or the peptide imaging procedure. The only codes available to hospitals were general imaging codes. Although this product was a breakthrough in medical technology, most hospitals were concerned that the lack of appropriate reimbursement would not cover the cost of the study. All claims filed under general codes would require paper claims with a copy of the imaging report attached. This process was not only time consuming and costly but appropriate reimbursement to the hospital was not guaranteed.


The Pinnacle Health Group designed and successfully implemented a reimbursement strategy which provided appropriate levels of reimbursement within nine months. As an interim solution, coding options were outlined for hospitals. Our staff also worked with individual hospitals and the local payers to assure that this new technology was reimbursed. In a concurrent effort, appropriate coding applications were submitted and a HCPCS code (for the peptide imaging agent) along with a CPT code (for peptide imaging for DVT) were both granted in less than nine months.


After careful research and evaluation of the issues at hand, The Pinnacle Health Group designed a reimbursement strategy that fit our client’s goals and objectives. We achieved appropriate levels of reimbursement and appropriate coding for the peptide agent and the study procedure. This permitted hospitals to initiate use of the key diagnostic study, showing reduced costs to the health care System by identifying better those patients at risk for stroke at an early stage. Additionally the efforts by The Pinnacle Health Group helped the company achieve their expected market objectives.

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